TFF Pharmaceuticals said that in vitro studies have demonstrated that the company’s inhaled niclosamide candidate completely inhibits the Omicron variant of SARS-CoV-2 at a concentration of 1 μM, noting that both nirmatrelvir (Paxlovid) and molnupiravir have been shown to require concentrations of 2.5 μM or greater to completely inhibit Omicron.
Enrollment in a Phase 1 trial of its inhaled niclosamide has been completed, the company said, with data expected to be released by the end of the first quarter of 2022. According to TFF, Phase 1 data have already demonstrated that a 6 mg dose of the dry powder niclosamide results in a concentration greater than 100 μM in the lung, and a 6 mg dose twice daily has been recommended for use in a Phase 2 trial.
TFF Pharmaceuticals CEO Glenn Mattes commented, “These supportive data increase our confidence that inhaled niclosamide could become an important new therapeutic to combat COVID-19 infection. Inhaled niclosamide’s demonstrable potency at such low concentrations should enable us to deliver reduced doses of the drug directly to the lung without compromising antirviral activity, thereby conferring a major potential advantage with respect to safety and tolerability. As more pathogenic variants of the SARS-CoV-2 virus emerge, it is essential that potent antiviral therapies are available to help significantly reduce the morbidity and mortality associated with this infection, particularly in the most vulnerable populations who suffer from cardiopulmonary deficiencies.”
Union Therapeutics acquired an option to license TFF’s inhaled niclosamide in August 2020. Union Therapeutics CEO Rasmus Toft-Kehler said, “We are encouraged by the news from TFF that niclosamide neutralizes the Omicron variant. The ability to deliver this antiviral directly to the site of infection with a simple at-home pocket-sized inhaler could be a game changer in the fight against COVID-19.”
Read the TFF Pharmaceuticals press release.
